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Health News: Medication - Tough laws planned for child drugs

1 min read
Most medicines used by children could be authorised and subject to specific research for child use by 2006 if tough new measures proposed by the European Commission become law.

According to the commission, as many as 50 per cent of medicines used to treat children and 90 per cent of medicines used in paediatric intensive care have not been approved for use by children, particularly for new-born babies.

Manufacturers have been slow to develop medicines for children due to the increased cost and difficulty of conducting clinical trials with them, and because adult medicines are often prescribed for children.

Under the measures, manufacturers proposing new medicines for children will be required to prove they have conducted clinical trials with children before their applications are cleared.

Those developing new medicines will be given patent extensions or market exclusivity of six months - or two years for rarer medicines - to help cover additional expenses and to act as an incentive to develop medicines.

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